|
AMAZINES.COM">Summary:“Avoiding 483 Observations and Warning Letters” is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will be organizing on October 17.John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the speaker at this webinar, which earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion. ----------------------------------------------------------------------------------------------------------------- Description:Many 483 cGMP observations are avoidable. Warning letters are quite preventable, but only if the medical devices company takes a little care at the time of audit. Despite this fact, many well-known, big names have had to contend cGMP observations, as a result of which they have had to incur fines running into millions, stiff penalties and lawsuits, not to speak about criminal prosecution. This webinar will enable participating companies to find simple and easy ways out of this possibility. It equips them with commonsense methods of avoiding Warning Letters when 483’s are received. It teaches them ways by which to avoid and counter negative audit. It lays emphasis on entropy, a major component of cGMP failure. This is the outline for this webinar: o The "tougher" U. S. FDA and Regulatory "Hot Buttons" o Recent news headlines - prominent / respected company failures o Why do Companies Fail When They Are in Compliance o Address Problems With an Eye to the Future o Reviewing Company Compliance to These Issues o Filling in the "Gaps" o Entropy –a major "player". ----------------------------------------------------------------------------------------------------------------- When: October 17, 10:00 AM PDT 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: John E. Lincoln, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o Senior management in Drugs, Devices, Biologics, Dietary Supplements o QA o RA o R&D o Engineering o Production o Operations o Consultants others tasked with product, process, validations, cGMP responsibilities ---------------------------------------------------------------------------------------------------------------- Duration:90 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact webinars@globalcompliancepanel.com Phone: 800-447-9407 AMAZINES.COM
Related Articles -
online Training, Good Manufacturing Practices, Code of Federal Regulations, ICH Q9, ISO 14971, Avoiding 483 Observations,
|
